Investigators at Brigham and Women’s Hospital take active role in ACTIV-4

The COVID-19 virus has taken over life as we know it, creating a novel environment for science in which collaboration is key and extraordinary speed is expected without sacrificing accuracy. Funded through Operation Warp Speed, the National Institutes of Health (NIH) launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership back in April. Since that time, Brigham and Women’s Hospital has taken a leadership role in launching a trial to determine if anticoagulant or antithrombotic therapy can reduce life-threatening cardiovascular or pulmonary complications from COVID-19.

ACTIV aims to coordinate a research strategy and prioritize the rapid development of treatments and vaccines. It consists of five adaptive master protocols. Brigham investigators are playing a lead role in the ACTIV-4 Antithrombotics Outpatient anticoagulant and antiplatelet trial, which is now underway.

“COVID-19 has overwhelmed the world because no one has prior immunity,” said Jean Connors, MD, of the Brigham’s Hematology Division and ACTIV-4 Antithrombotics Outpatient trial principal investigator. “This lack of immunity often results in significant inflammation and activation of coagulation. We think that patients who get diagnosed with COVID-19 – but aren’t admitted to the hospital – appear to have increased risk for developing blood clots and pulmonary microvascular thrombosis.”

“We are honored that Operation Warp Speed and the NIH came to us at the Brigham to coordinate this effort,” said Paul Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention and ACTIV-4 Antithrombotics Outpatient Trial chair. “I am particularly pleased with how our Brigham support staff creatively built a nation-wide "low-touch" trial structure in an incredibly short period of time, reflecting the emergency we are all dealing with.”